Patient Satisfaction Clinical Trial
Official title:
The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
Verified date | December 2023 |
Source | Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation
Status | Completed |
Enrollment | 92 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Between 18-70 years old who had scheduled colonoscopy appointments Exclusion Criteria: - Anxiety and panic disorders - Urgent endoscopic intervention - Advanced dementia - Hearing problems - Anatomical or inflammatory disorders in the external ear canals |
Country | Name | City | State |
---|---|---|---|
Turkey | Abdurrahman Yurtaslan Oncology and Training Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital |
Turkey,
Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18. — View Citation
Tani A, Tartarisco G, Vagheggini G, Vaccaro C, Campana S, Tomaiuolo F. Binaural beats reduce feeling of pain and discomfort during colonoscopy procedure in not-sedated patients: A randomized control trial. Complement Ther Clin Pract. 2022 Aug;48:101605. d — View Citation
Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS-anxiety | The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety | immediately before being taken into the procedure room and 5 minutes after the procedure | |
Primary | VAS-pain | The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety | 5 minutes after the procedure | |
Primary | The Modified Gloucester Comfort Scale | The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points. | During the procedure | |
Secondary | Patient satisfaction | After the procedure, the patients were asked a series of questions for procedure evaluation (worse than expected, as expected, better than expected) and their willingness to have endoscopy again for their health (no, yes). The binaural music group was asked a three-item question with "yes-not sure-no" responses, inquiring whether the music increased relaxation and if they would like to listen to the same music again during a repeat procedure. | 5 minutes after the procedure | |
Secondary | Heart rate | The comparison of heart rate in the music and control groups | Within 20 minutes pre-procedure and 5 minutes after the procedure | |
Secondary | Blood pressure | The comparison of systolic and diastolic blood pressure in the music and control groups | Within 20 minutes pre-procedure and 5 minutes after the procedure | |
Secondary | cecal insertion time(minutes) | Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice. | during the procedure | |
Secondary | withdrawal time (minutes) | Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient. | during the procedure | |
Secondary | polyp detection rate | It will be assessed by recording the encountered polyps during colonoscopy. | during the procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04079543 -
NPO and Patient Satisfaction in the Cath Lab
|
N/A | |
Enrolling by invitation |
NCT05053958 -
Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.
|
N/A | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT04774562 -
The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery
|
N/A | |
Terminated |
NCT04604340 -
Radial Versus Femoral Arterial Access for Cerebral Angiography in Adolescents
|
N/A | |
Recruiting |
NCT04539210 -
Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework Versus Cast One, Patient Satisfaction Assessment.
|
N/A | |
Completed |
NCT02924974 -
Spinal Morphine in Robotic Assisted Radical Prostatectomy
|
Phase 4 | |
Completed |
NCT01052415 -
POL and Access Intervention to Reduce HIV Stigma Among Service Providers in China
|
N/A | |
Recruiting |
NCT06044103 -
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
|
Phase 4 | |
Not yet recruiting |
NCT05670080 -
Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?
|
N/A | |
Completed |
NCT06114524 -
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
|
N/A | |
Completed |
NCT06141122 -
The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
|
N/A | |
Not yet recruiting |
NCT04534868 -
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
|
N/A | |
Completed |
NCT04823390 -
Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits
|
Phase 1 | |
Recruiting |
NCT05884684 -
What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
|
N/A | |
Recruiting |
NCT05613439 -
The Fast-track Centre for Hip and Knee Replacement Database
|
||
Recruiting |
NCT06451510 -
Knee Osteoarthritis in the Region of Norrbotten
|
||
Completed |
NCT04420000 -
Effects of Mindfulness Therapy in Patients With Acromegaly and Cushing
|
N/A | |
Withdrawn |
NCT04625842 -
Focus Group Interview Study on Patient Experiences and Satisfaction
|
N/A | |
Recruiting |
NCT04842240 -
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
|